NCT00265720

Brief Summary

Colorectal cancer is the second deadliest among cancers and disproportionately affects African Americans. The Colorectal Cancer Screening Intervention Trial(CCSIT) project has as its goal to test three interventions designed to increase screening rates among medically underserved African Americans in the Metropolitan Atlanta area. It is designed to increase awareness of modifiable risk factors and promote the benefits of screening as a means of early detection of colorectal cancer. mportance of being screened for colorectal cancer,African Americans continue to be disproportionately affected by this disease. The Colorectal Cancer Screening

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

4.3 years

First QC Date

December 13, 2005

Last Update Submit

February 3, 2009

Conditions

Keywords

African AmericansColorectal Cancer ScreeningColorectal CancerColorectal Cancer and African AmericansCancer Disparities

Outcome Measures

Primary Outcomes (1)

  • Colorectal Cancer Screening Rate; This measurement(Impact) is taken 90 days from last intervention session. If a person is not screened, an additional measurement(Post-Impact) is taken 90 days from the Impact.

Secondary Outcomes (1)

  • Knowledge, Attitudes and Beliefs; this measurement is taken at baseline and post intervention session. Sessions vary by intervention group after the initial recruitment sessions:

Study Arms (4)

Control

PLACEBO COMPARATOR

Written materials only

Other: Control

Reduced out-of-pocket expense

EXPERIMENTAL

Reimbursed up to $500 out-of-pocket expense for colorectal cancer screening

Other: Reduced out of pocket expense

One-on-one education

EXPERIMENTAL

Individual education with a health educator on CRC screening

Behavioral: one on one education

Group Education

EXPERIMENTAL

Education on CRC screening in a small group with a health educator

Behavioral: Group education

Interventions

ControlOTHER

Written materials only

Control

Reimbursed up to $500 out of pocket expense for CRC screening

Reduced out-of-pocket expense

one on one education with a health educator

One-on-one education
Group educationBEHAVIORAL

Education in a small group

Group Education

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American
  • Previously not screened for colorectal cancer according to ACS guidelines
  • Reside in Fulton,,Gwinett,Cobb,Clayton and DeKalb counties
  • years of age or older

You may not qualify if:

  • Non-African American
  • Less than 50 years of age
  • Previously screened consistent with ACS guideline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310-1495, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Daniel Blumenthal, M.D., M.P.H.

    Morehouse School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 15, 2005

Study Start

March 1, 2003

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations